PL3518924T3 - Postacie stałej dyspersji ryfaksyminy - Google Patents

Postacie stałej dyspersji ryfaksyminy

Info

Publication number
PL3518924T3
PL3518924T3 PL17857495.0T PL17857495T PL3518924T3 PL 3518924 T3 PL3518924 T3 PL 3518924T3 PL 17857495 T PL17857495 T PL 17857495T PL 3518924 T3 PL3518924 T3 PL 3518924T3
Authority
PL
Poland
Prior art keywords
rifaximin
solid dispersion
dispersion forms
forms
solid
Prior art date
Application number
PL17857495.0T
Other languages
English (en)
Inventor
Pam Golden
Mohammed A. KABIR
Original Assignee
Salix Pharmaceuticals, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Salix Pharmaceuticals, Inc. filed Critical Salix Pharmaceuticals, Inc.
Publication of PL3518924T3 publication Critical patent/PL3518924T3/pl

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/437—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/2853—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Inorganic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dispersion Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
PL17857495.0T 2016-09-30 2017-09-29 Postacie stałej dyspersji ryfaksyminy PL3518924T3 (pl)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201662402119P 2016-09-30 2016-09-30
PCT/US2017/054288 WO2018064472A1 (en) 2016-09-30 2017-09-29 Solid dispersion forms of rifaximin

Publications (1)

Publication Number Publication Date
PL3518924T3 true PL3518924T3 (pl) 2023-01-09

Family

ID=61762926

Family Applications (1)

Application Number Title Priority Date Filing Date
PL17857495.0T PL3518924T3 (pl) 2016-09-30 2017-09-29 Postacie stałej dyspersji ryfaksyminy

Country Status (11)

Country Link
US (8) US10874647B2 (pl)
EP (2) EP3518924B1 (pl)
JP (1) JP7027412B2 (pl)
KR (3) KR20230023043A (pl)
CN (1) CN110072525B (pl)
CA (1) CA3038312A1 (pl)
ES (1) ES2929768T3 (pl)
PL (1) PL3518924T3 (pl)
PT (1) PT3518924T (pl)
RS (1) RS63751B1 (pl)
WO (1) WO2018064472A1 (pl)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP7027412B2 (ja) * 2016-09-30 2022-03-01 サリックス ファーマスーティカルズ，インコーポレーテッド リファキシミンの固体分散体の形態
BR112022003500A2 (pt) * 2019-09-24 2022-05-24 Bausch Health Ireland Ltd Formulações líquidas de rifaximina
US20230027192A1 (en) * 2019-11-25 2023-01-26 United States Government As Represented By The Department Of Veterans Affairs Methods of using soluble solid dispersions of rifaximin
EP4125888A1 (en) * 2020-03-24 2023-02-08 Bausch Health Ireland Limited Solid dispersions of rifaximin for the treatment of overt hepatic encephalopathy
JP7825575B2 (ja) 2020-06-26 2026-03-06 バウシュ ヘルス アイルランド リミテッド 標的化放出リファキシミン組成物
US20230398102A1 (en) 2020-10-29 2023-12-14 Bausch Health Ireland Limited Rifaximin liquid formulations for use inthe treatment of sickle cell disease
CN120112284A (zh) * 2022-08-19 2025-06-06 米拉蒂治疗股份有限公司 阿达格拉西布固体药物组合物

Family Cites Families (38)

* Cited by examiner, † Cited by third party
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IT1154655B (it) 1980-05-22 1987-01-21 Alfa Farmaceutici Spa Derivati imidazo-rifamicinici metodi per la loro preparazione e loro uso come sostanza ad azione antibatterica
IT1199374B (it) 1984-05-15 1988-12-30 Alfa Farmaceutici Spa Processo per la preparazione di pirido-imidazo-rifamicine
US4943597A (en) 1988-12-07 1990-07-24 The Dow Chemical Company Polyether polyol formulations for hard CFC replacement by water blowing in rigid polyurethane foams
GB9109862D0 (en) 1991-05-08 1991-07-03 Beecham Lab Sa Pharmaceutical formulations
IT1320176B1 (it) 2000-12-22 2003-11-26 Nicox Sa Dispersioni solide di principi attivi nitrati.
GB0104752D0 (en) 2001-02-27 2001-04-18 Astrazeneca Ab Pharmaceutical compositions
BR0210520A (pt) 2001-06-22 2004-06-22 Pfizer Prod Inc Composições farmacêuticas de dispersões de fármacos amorfos misturados com polìmeros
GB0123400D0 (en) 2001-09-28 2001-11-21 Novartis Ag Organic compounds
US7902206B2 (en) 2003-11-07 2011-03-08 Alfa Wassermann, S.P.A. Polymorphic forms α, β and γ of rifaximin
ITMI20032144A1 (it) 2003-11-07 2005-05-08 Alfa Wassermann Spa Forme polimorfe di rifaximina, processi per ottenerle e
US7906542B2 (en) 2004-11-04 2011-03-15 Alfa Wassermann, S.P.A. Pharmaceutical compositions comprising polymorphic forms α, β, and γ of rifaximin
JP2007517016A (ja) 2003-12-31 2007-06-28 ファイザー・プロダクツ・インク 低溶解性薬剤及びポロキサマーの固体組成物
MY191349A (en) 2004-08-27 2022-06-17 Bayer Pharmaceuticals Corp New pharmaceutical compositions for the treatment of hyper-proliferative disorders
PT1698630E (pt) 2005-03-03 2014-09-15 Alfa Wassermann Spa Novas formas polimorfas de rifaximina, processos para a sua produção e a sua utilização nas preparações medicinais
ITBO20050123A1 (it) 2005-03-07 2005-06-06 Alfa Wassermann Spa Formulazioni farmaceutiche gastroresistenti contenenti rifaximina
CA2645566A1 (en) 2006-03-20 2007-09-27 Vertex Pharmaceuticals Incorporated Pharmaceutical compositions
US20080095754A1 (en) 2006-10-18 2008-04-24 Burke Susan E Ophthalmic compositions comprising diglycine
PL2011486T5 (pl) 2007-07-06 2016-09-30 Lupin Ltd Farmaceutyczne kompozycje rifaksyminy
WO2009008005A1 (en) * 2007-07-06 2009-01-15 Lupin Limited Pharmaceutical compositions of rifaximin
AU2016203925B2 (en) * 2007-07-06 2016-10-20 Lupin Limited Pharmaceutical compositions of rifaximin
AU2014202520A1 (en) 2007-07-06 2014-05-29 Lupin Limited Pharmaceutical Compositions of Rifaximin
US8486956B2 (en) 2008-02-25 2013-07-16 Salix Pharmaceuticals, Ltd Forms of rifaximin and uses thereof
GEP20135898B (en) 2008-02-25 2013-08-12 Salix Pharmaceuticals Ltd Rifaximin forms and usage
BRPI0908026B8 (pt) 2008-02-26 2021-05-25 Salix Pharmaceuticals Ltd uso de rifaximina no tratamento de doenças do intestino
EP2105130A1 (de) 2008-03-25 2009-09-30 Ratiopharm GmbH Pharmazeutische Formulierung und Verfahren zu deren Herstellung
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HRP20200284T1 (hr) * 2008-10-02 2020-07-10 Salix Pharmaceuticals, Ltd. Postupci liječenja hepatičke encefalopatije
KR101906177B1 (ko) 2008-12-10 2018-10-10 시플라 리미티드 리팍시민 복합체
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WO2011061748A1 (en) 2009-11-19 2011-05-26 Strides Arcolab Limited Rifaximin premix
IT1398550B1 (it) * 2010-03-05 2013-03-01 Alfa Wassermann Spa Formulazioni comprendenti rifaximina utili per ottenere un effetto prolungato nel tempo
NZ602288A (en) 2010-03-10 2014-02-28 Abbvie Bahamas Ltd Solid compositions comprising amorphous (2r,6s,13as,14ar,16as,z)-n-(cyclopropylsulfonyl)-6-(5-methylpyrazine-2-carboxamido)-5,16-dioxo-2-(phenanthridin-6-yloxy)-1,2,3,5,6,7,8,9,10,11,13a,14,14a,15,16,16a-hexadecahydrocyclopropa[e]pyrrolo[1,2-a][1,4]diazacyclopentadecine-14a-carboxamide
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JP7027412B2 (ja) 2016-09-30 2022-03-01 サリックス ファーマスーティカルズ，インコーポレーテッド リファキシミンの固体分散体の形態

Also Published As

Publication number Publication date
US10874647B2 (en) 2020-12-29
CA3038312A1 (en) 2018-04-05
EP4137132A1 (en) 2023-02-22
EP3518924A4 (en) 2020-04-29
JP2019529494A (ja) 2019-10-17
US20250367175A1 (en) 2025-12-04
US20250082616A1 (en) 2025-03-13
KR20190062458A (ko) 2019-06-05
EP3518924B1 (en) 2022-08-10
US20260014126A1 (en) 2026-01-15
ES2929768T3 (es) 2022-12-01
US20220040157A1 (en) 2022-02-10
CN110072525A (zh) 2019-07-30
US11311521B2 (en) 2022-04-26
US20210401813A1 (en) 2021-12-30
EP4137132B1 (en) 2026-03-18
PT3518924T (pt) 2022-10-27
WO2018064472A1 (en) 2018-04-05
KR20230023043A (ko) 2023-02-16
WO2018064472A8 (en) 2019-02-14
US20210205279A1 (en) 2021-07-08
US20190224175A1 (en) 2019-07-25
KR20240124428A (ko) 2024-08-16
EP3518924A1 (en) 2019-08-07
US11129817B2 (en) 2021-09-28
RS63751B1 (sr) 2022-12-30
US11660292B2 (en) 2023-05-30
CN110072525B (zh) 2022-12-02
KR102494049B1 (ko) 2023-01-31
US20240100028A1 (en) 2024-03-28
JP7027412B2 (ja) 2022-03-01

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